Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder

April 30, 2026 updated by: Dr. Caroline Pukall

Examining the Effectiveness of a Group Cognitive-behavioural Treatment Program for Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia

This study seeks to provide information regarding the effectiveness of a virtual, synchronous cognitive behavioural therapy (CBT) group program for women with Persistent Genital Arousal Disorder/Genitopelvic Dysesthesia (PGAD/GPD). The program consists of 8 weekly sessions of two hours each, which focus on education and understanding, and learning skills and strategies to manage PGAD/GPD symptoms, and related mental health and lifestyle impacts, as well as structured opportunities for discussion and shared reflection. The group therapy program involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT). Participants in the present study will provide responses to online surveys (before, during, and immediately after treatment, also 3 and 6 months after treatment) regarding their PGAD/GPD symptoms, mental health symptoms, and sexual wellness (sexual pleasure and distress).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Sexual Health Research Laboratory, Department of Psychology, Queen's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • at least 18 years of age
  • fluent in English
  • have a physician-based diagnosis of PGAD/GPD
  • reside in Ontario, Canada
  • be comfortable answering questions about their health (mental and physical) and sexuality in online surveys
  • be comfortable discussing their mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on

Exclusion Criteria:

  • under the age of 18 years
  • nonfluent in English
  • lack of physician based diagnosis of PGAD/GPD
  • not comfortable with answering questions about mental, physical, sexual health
  • not comfortable with discussing mental and physical health and PGAD/GPD symptoms in group online therapy sessions with video on
  • mental or physical health conditions that preclude involvement in group therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive behavioural therapy
The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).
Behavioral: Cognitive behavioural therapy
The group therapy program (virtual, synchronous) involves elements based in Cognitive Behavioural Therapy (CBT), Acceptance and Commitment Therapy (ACT), and Dialectical Behaviour Therapy (DBT).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom intensity
Time Frame: Baseline
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Baseline
Symptom intensity
Time Frame: Week 1 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 1 of program
Symptom intensity
Time Frame: Week 2 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 2 of program
Symptom intensity
Time Frame: Week 3 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 3 of program
Symptom intensity
Time Frame: Week 4 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 4 of program
Symptom intensity
Time Frame: Week 5 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 5 of program
Symptom intensity
Time Frame: Week 6 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 6 of program
Symptom intensity
Time Frame: Week 7 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 7 of program
Symptom intensity
Time Frame: Week 8 of program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
Week 8 of program
Symptom intensity
Time Frame: 3 months after the end of the program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
3 months after the end of the program
Symptom intensity
Time Frame: 6 months after the end of the program
Symptom intensity on a scale of 0 (no symptoms) to 10 (extremely intense symptoms). Range is 0-10. Higher scores are worse.
6 months after the end of the program
Symptom distress
Time Frame: Baseline
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Baseline
Symptom distress
Time Frame: Week 1 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 1 of program
Symptom distress
Time Frame: Week 2 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 2 of program
Symptom distress
Time Frame: Week 3 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 3 of program
Symptom distress
Time Frame: Week 4 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 4 of program
Symptom distress
Time Frame: Week 5 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 5 of program
Symptom distress
Time Frame: Week 6 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 6 of program
Symptom distress
Time Frame: Week 7 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 7 of program
Symptom distress
Time Frame: Week 8 of program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
Week 8 of program
Symptom distress
Time Frame: 3 months after the end of the program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
3 months after the end of the program
Symptom distress
Time Frame: 6 months after the end of the program
Symptom distress on a scale of 0 (no distress) to 10 (extreme distress). Range is 0-10. Higher scores are worse.
6 months after the end of the program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom catastrophizing
Time Frame: Baseline
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Baseline
Symptom catastrophizing
Time Frame: Week 1 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 1 of program
Symptom catastrophizing
Time Frame: Week 2 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 2 of program
Symptom catastrophizing
Time Frame: Week 3 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 3 of program
Symptom catastrophizing
Time Frame: Week 4 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 4 of program
Symptom catastrophizing
Time Frame: Week 5 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 5 of program
Symptom catastrophizing
Time Frame: Week 6 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 6 of program
Symptom catastrophizing
Time Frame: Week 7 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 7 of program
Symptom catastrophizing
Time Frame: Week 8 of program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
Week 8 of program
Symptom catastrophizing
Time Frame: 3 months after the end of the program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
3 months after the end of the program
Symptom catastrophizing
Time Frame: 6 months after the end of the program
Pain Catastrophizing Scale, adapted to symptoms. Range is 0-52. Higher scores are worse.
6 months after the end of the program
Symptom self-efficacy
Time Frame: Baseline
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Baseline
Symptom self-efficacy
Time Frame: Week 1 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 1 of program
Symptom self-efficacy
Time Frame: Week 2 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 2 of program
Symptom self-efficacy
Time Frame: Week 3 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 3 of program
Symptom self-efficacy
Time Frame: Week 4 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 4 of program
Symptom self-efficacy
Time Frame: Week 5 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 5 of program
Symptom self-efficacy
Time Frame: Week 6 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 6 of program
Symptom self-efficacy
Time Frame: Week 7 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 7 of program
Symptom self-efficacy
Time Frame: Week 8 of program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
Week 8 of program
Symptom self-efficacy
Time Frame: 3 months after the end of the program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
3 months after the end of the program
Symptom self-efficacy
Time Frame: 6 months after the end of the program
Pain Self-Efficacy Scale, adapted to symptoms. Range is 0-60. Higher scores are better.
6 months after the end of the program
Resilience
Time Frame: Baseline
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Baseline
Resilience
Time Frame: Week 1 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 1 of program
Resilience
Time Frame: Week 2 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 2 of program
Resilience
Time Frame: Week 3 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 3 of program
Resilience
Time Frame: Week 4 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 4 of program
Resilience
Time Frame: Week 5 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 5 of program
Resilience
Time Frame: Week 6 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 6 of program
Resilience
Time Frame: Week 7 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 7 of program
Resilience
Time Frame: Week 8 of program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
Week 8 of program
Resilience
Time Frame: 3 months after the end of the program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
3 months after the end of the program
Resilience
Time Frame: 6 months after the end of the program
Brief Resilience Scale. Range is 6-30. Higher scores are better.
6 months after the end of the program

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sexual distress
Time Frame: Baseline
Sexual distress scale. Range is 0-20. Higher scores are worse.
Baseline
Sexual distress
Time Frame: Week 4 of program
Sexual distress scale. Range is 0-20. Higher scores are worse.
Week 4 of program
Sexual distress
Time Frame: Week 8 of program
Sexual distress scale. Range is 0-20. Higher scores are worse.
Week 8 of program
Sexual distress
Time Frame: 3 months after the end of the program
Sexual distress scale. Range is 0-20. Higher scores are worse.
3 months after the end of the program
Sexual distress
Time Frame: 6 months after the end of the program
Sexual distress scale. Range is 0-20. Higher scores are worse.
6 months after the end of the program
Anxiety
Time Frame: Baseline
Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.
Baseline
Anxiety
Time Frame: Week 4 of program
Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.
Week 4 of program
Anxiety
Time Frame: Week 8 of program
Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.
Week 8 of program
Anxiety
Time Frame: 3 months after the end of the program
Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.
3 months after the end of the program
Anxiety
Time Frame: 6 months after the end of the program
Generalized Anxiety Scale. Range is 0-21. Higher scores are worse.
6 months after the end of the program
Depression
Time Frame: Baseline
Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.
Baseline
Depression
Time Frame: Week 4 of program
Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.
Week 4 of program
Depression
Time Frame: Week 8 of program
Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.
Week 8 of program
Depression
Time Frame: 3 months after the end of the program
Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.
3 months after the end of the program
Depression
Time Frame: 6 months after the end of the program
Patient Health Questionnaire-9. Range is 0-27. Higher scores are worse.
6 months after the end of the program
Symptom-related disability
Time Frame: Baseline
Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.
Baseline
Symptom-related disability
Time Frame: Week 4 of program
Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.
Week 4 of program
Symptom-related disability
Time Frame: Week 8 of program
Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.
Week 8 of program
Symptom-related disability
Time Frame: 3 months after the end of the program
Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.
3 months after the end of the program
Symptom-related disability
Time Frame: 6 months after the end of the program
Pain disability index, adapted for symptoms. Range is 0-70. Higher scores are worse.
6 months after the end of the program
Sexual function
Time Frame: Baseline
Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.
Baseline
Sexual function
Time Frame: Week 4 of program
Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.
Week 4 of program
Sexual function
Time Frame: Week 8 of program
Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.
Week 8 of program
Sexual function
Time Frame: 3 months after the end of the program
Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.
3 months after the end of the program
Sexual function
Time Frame: 6 months after the end of the program
Arizona Sexual Experiences Scale, adapted in terms of inclusive language. Range is 5-30. Higher scores are worse.
6 months after the end of the program
Alliance
Time Frame: Week 1 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 1 of program
Alliance
Time Frame: Week 2 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 2 of program
Alliance
Time Frame: Week 3 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 3 of program
Alliance
Time Frame: Week 4 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 4 of program
Alliance
Time Frame: Week 5 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 5 of program
Alliance
Time Frame: Week 6 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 6 of program
Alliance
Time Frame: Week 7 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 7 of program
Alliance
Time Frame: Week 8 of program
Working Alliance with Therapist: Session Rating Scale. Four scales rated from 0-10 (range is 0-40), with higher scores indicating a better alliance.
Week 8 of program
Therapy group cohesion
Time Frame: Week 1 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 1 of program
Therapy group cohesion
Time Frame: Week 2 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 2 of program
Therapy group cohesion
Time Frame: Week 3 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 3 of program
Therapy group cohesion
Time Frame: Week 4 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 4 of program
Therapy group cohesion
Time Frame: Week 5 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 5 of program
Therapy group cohesion
Time Frame: Week 6 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 6 of program
Therapy group cohesion
Time Frame: Week 7 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 7 of program
Therapy group cohesion
Time Frame: Week 8 of program
The Group Climate Questionnaire. 12 items total, 3 subscales. Items rated from 0 (not at all) to 7 (extremely). Range for each subscale due to averaging items is 0-7. Higher scores are better.
Week 8 of program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Caroline Pukall

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Caroline Pukall, PhD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 379631-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be available to other researchers after publication of the results.

IPD Sharing Time Frame

De-identified data will be available to other researchers for 2 years after publication of the results.

IPD Sharing Access Criteria

Please email the PI at caroline.pukall@queensu.ca

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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